Maternal and fetal outcomes of various lipid-lowering treatment regimens during pregnancy: insights from the czech national registry 2012-2023

Introduction About 20% of pregnant women suffer from elevated lipid levels during pregnancy. Normally, non-pharmacological therapy is sufficient for correction. In particular, patients with genetic familial hypercholesterolaemia without consistent therapy during pregnancy are at high cardiovascular risk. Purpose This study aimed to analyse the outcomes of pregnancy in women treated by different lipid-lowering drugs. Methodology Nationwide data on all births and abortions in the period 2012-2023 in the Czech Republic were obtained from the National Registry of Reproductive Health (NRRZ) and the National Registry of Reimbursable Health Services (NRHZS). Women were sorted into women with treatment initiation during pregnancy and women with pre-existing lipid disorders who were prescribed within one year before pregnancy any lipid-lowering drug from selected ATC groups (C10A, C10B). Hypoxia in the new-born was defined as pH <7.1 or Apgar score <8 present after delivery. For all factors, univariate logistic regression was used to calculate the odds ratios (OR) of adverse outcomes. Results There were total 1,342,432 deliveries in the 11-year period. 1,100 women were treated with lipid-lowering drugs during pregnancy. Odds ratios for caesarean section, pre-term delivery, low birth weight and new-born hypoxia in women using different lipid-lowering classes and drugs are shown in the Figure. Risk of maternal and fetal complications was found to be higher with cholestyramin compared to fibrates and even to statins. Although used in limited numbers, atorvastatin and rosuvastatin appeared to be comparably safe but simvastatin had higher odds ratio for complications. Fixed combination of statin and antihypertensive drugs was associated with higher risk of adverse outcomes, probably due to the combination with amlodipine. Conclusion Atorvastatin and rosuvastatin seem to have relatively low the risk of adverse maternal and fetal outcomes, comparable to fibrates. Cholestyramin and fixed combination statin with amplodipine are associated with increased risk.